Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-202A

Phase 3

Not yet recruiting

• Conditions: Essential Hypertension
• Interventions: Drug: sacubitril/valsatran(dose maintenance); Drug: sacubitril/valsartan(dose increasing); Drug: Valsartan

• Registration Number: NCT06643819
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-202A(Sacubitril∙Valsartan)

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-14
• Study First Submitted: 2024-10-14
• Study First Submitted QC: 2024-10-14
• Last Update Submitted: 2024-10-14
• Study First Posted: 2024-10-16
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

• Participants who are 19 years old or older.
• Participants who have voluntarily decided to participate in this clinical trial and signed ICF.

Exclusion Criteria

• Participants with a history of secondary hypertension or suspected secondary hypertension.
• Participants with a orthostatic hypotension.
• Participants who require combination administration of antihypertensive drugs other than clinical trial drugs during the clinical trial participation period.
• Participants with type 1 diabetes or poorly controlled diabetes.
• Participants who treated other clinical trial drugs within 4 weeks of screening visit.
• Participants with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening
• Pregnant women, lactating women, or Subjects who do not agree to use appropriate contraception during the clinical trial period and for two weeks after the end of administration of the last clinical trial drug
• Participants who are unable to participate in this clinical trial at the discretion of the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Group1	sacubitril/valsatran(dose maintenance)	-
Test Group2	sacubitril/valsartan(dose increasing)	-
CONTROL	Valsartan	-

Primary Outcome Measures

Name	Time	Method
change from baseline in MASBP(Mean Ambulatory Systolic Blood Pressure)	10 weeks after baseline	The purpose of Clinical Trial is confirmation that test group 2 (Sacubitril∙Valsartan 200mg) is superior to control group (Valsartan 160mg)

Trial Locations

Locations (1)

Wonju Severance Christian Hospital; 🇰🇷 Wonju, Korea, Republic of